METHOD FOR SECURING MEDICAL DEVICES TO TREAT OBESITY, GASTRO-ESOPHAGEAL REFLUX DISEASE (GERD) AND IRRITABLE BOWEL SYNDROME (iBS) REVERSIBLY

ABSTRACT

A medical staple formed from a nitinol wire, the staple having two elongated arms which extend upwardly and outwardly from a central loop in two opposing generally semicircular courses forming an arc extending upwardly and outwardly and an end second comprising a sharpened endpoint, the endpoint being the arms bendable under resistance, is disclosed. In some embodiments the arms extend upwardly on a parallel course and then outwardly. The material is preferably an alloy with hyperelastic characteristics. The staples are placed in a flexible endoscope and a lumen catheter within the endoscope, using a hook or forceps in the lumen catheter having a distal end in the lumen of the catheter and the staple distal to the forceps in folded configuration with the arms folded inward in the lumen catheter, positioning the distal end of the lumen catheter at a location in the patient&#39;s gastrointestinal tract where stapling is desired, moving the forceps distally so as to force the staple forward out of the lumen catheter and cause the end points to pierce the patient&#39;s inner wall of the gastrointestinal tract.

CROSS REFERENCE TO RELATED APPLICATION

This application claims benefit of provisional application Ser. No.60/747,712 filed May 19, 2006 and 60/884,770 filed Jan. 12, 2007.

BACKGROUND OF THE INVENTION

The present invention relates to the field of medicine, particularly tosecuring medical devices to tissue or organs, and to reversing theprocedure and removing the devices.

The most common way to secure medical tissues to tissues or organs is bystapling with conventional surgical staples formed from a single lengthof wire in an approximate U-shape. For example, McGarry, et al., in U.S.Pat. No. 5,366,479, disclose endoscopic application of staples forattaching surgical mesh to body tissue in laparoscopic hernia surgery.In this patent, the stapler is a rigid instrument and cannot be usedthrough the mouth into the esophagus where a flexible instrument isneeded. Furthermore, the stapling system of this patent is notreversible.

For certain types of devices placed through the mouth, conventionalstapling with a rigid stapler is not possible and so variousalternatives using flexible instruments have been devised. For example,to treat a condition known as Gastro-Esophageal Reflux Disease (GERD), atubular valve has been designed for letting free passage of food fromthe esophagus into the stomach but stopping food and gastric contentsuch as hydrochloric acid and bile from refluxing from the stomach intothe esophagus. Godin, U.S. Pat. No. 5,861,036, described aGastro-esophageal Anti-Reflux Device (GARD) and Godin, U.S. Pat. No.6,764,518 described a system for securing the GARD comprising a ringwhich could be collapsed into a smaller diameter for placement throughthe mouth and placed in a hiatus hernia after calibration of thediameter of the hernia with a catheter. Such ring was designed to placethe GARD tubular valve in the lower esophagus or in a hiatus herniaassociated with severe GERD and keep it in place for a significantamount of time, such as months and years, as severe GERD is a chroniccondition.

While the aforementioned method of placing a GARD worked for somepatients, it was insufficient in certain cases.

In a different approach to addressing GERD, endoluminal fundoplicationsurgery, a flexible endoscope was disclosed by Adams, et al., in U.S.Pat. No. 6,736,828, as being useful in endoluminal fundoplicationsurgery where a bonding agent is injected into tissue which forms anintussusception formed by pulling a selected portion of the esophagusinto the stomach and displacing a fundus portion of the stomach towardsthe esophagus, placing a fastener across the intussusception formaintaining an esophageal wall and a gastric wall forming theintussusception adjacent to one another and then injecting the bondingagent to bond the intussusception. The disclosed fasteners are allsymmetrical at both ends. Adams, et al., did not describe a flexibleecho endoscopic procedure. The intussusception site is located by Adams,et al., by viewing the gastroesophogeal junction (GEJ) through theendoscope. The fastener is preferably made of polypropylene but canalternatively be made of a biocompatible material and can be aT-fastener. The fastener is inserted through a hypotube which firstpenetrates tissue of both the esophageal and gastric walls; then theT-fastener is inserted so the distal end of the T-fastener engages thegastric wall as the hypotube is retracted; and then the hypotube isfurther retracted into the sheath of a fastener delivery device. Theproximal end of the T-fastener is pulled out of the hypotube by thetension exerted from the distal end of the T-fastener and then theproximal end seats against the inner wall of the esophagus, therebyholding the gastric wall and the esophagus together. One of theT-fasteners has a simple T-bar at each end, referred to herein as afastener since the T-bars are normally biased in a T-configuration withrespect to the longer joining portion but can be maintained in a reduceddiameter configuration, with the T-bars “tilted” or compressed towardthe longer joining portion, while inserted and maintained in a hypotubesuch as a hypodermic needle delivery device. Such fasteners are advancedthrough the hypotube until the distal portion exits the distal end ofthe hypotube delivery device and then regains its normally radiallyexpanded position. In Adams, the T-bars when placed on both sides of theintussusception are visible on both sides with conventional endoscopesas one T-bar is on the esophageal side and the other one on the gastricfundal side. No echoendoscope is necessary and none is described. TheAdams T-bars are not used to hold a device attached to the mucosa.

A system for suturing, tissue fixation, and transgastric penetration tofacilitate surgery on the wall of the GI tract and adjacent holloworgans under Endoscopic Ultrasound (EUS) control was described byFritscher-Ravens, et al., in Gastrointestinal Endoscopy, vol. 56, No. 5,2002, pgs. 737 to 742. In this paper, one single tag is placed under EUScontrol through the mucosa. A free piece of thread as described in FIGS.A-E on page 738 comes out of the tag and from the tip of the needle thatis modified in order to let the thread come out of the needle. The freethread has then to be attached using either suturing systems or pledgetsor tying knots that are not easily done or used through a flexibleendoscope. Furthermore, the Fritscher-Ravens, et al., system was notdescribed for use for securing medical devices, for example a GARD, tothe gastrointestinal tract or any other organ.

A rigid rather than flexible laparoscopic surgery appliance forinstalling temporary plastic resorbable fasteners, for example forfixing parietal and visceral reinforcements, is described by Bailly, etal., in U.S. Pat. No. 6,779,701. Bailly, et al., teach binding nets fortreatment of inguinal hernias. A plunger for forcing the catching barsto pivot is disclosed.

A self-securing suture wire with a T-shaped toggle designed forinsertion into a bodily structure, tissue, or organ, delivered by aslotted needle, is disclosed by Levinson, et al., in U.S. Pat. No.6,596,014. The toggle end portion can be made of nitinol, stainlesssteel, or biocompatible material. The suture is designed to be placed ina blood vessel from the outside of the vessel.

A T-bar fastener with a sharp end or point on the bar-like head portion,or T, so that the sharp end or point embeds itself in body tissue tosecurely anchor the T-bar head is disclosed by Richards, et al., in U.S.Pat. No. 4,669,473. A tool receives a fastener with the bar-like headpositioned inside a bore of a sheath and the filament portion of thefastener extending out through a slot in the tool bore, the head makinga sliding fit in the sheath.

Staples of various configurations have been suggested for unrelatedsurgical procedures and applications, for example for repair ofarteries, Phillips, et al., US Patent Pub. 2003/0033006, disclose adevice with a central section for abutment contact with the inner wallof a graft and two elongate members with distal ends for contacting theouter wall of the artery when the device is pierced through the graftand the artery. In FIGS. 7 and 8 of Phillips, et al., a device with acentral loop is shown in unstressed configuration and in stressedconfiguration in a delivery tube.

A suture anchor was described by Gatturna, et al., U.S. Pat. No.5,192,303 wherein a coupling member at one end and a barb on the otherend are used to anchor a suture to bone.

Irnich, et al., U.S. Pat. No. 3,814,104, disclose a pacemaker electrodewith an electrode tip having two crossing arms and a central loop.

It is an object of the present invention to provide a method andapparatus for esophageal and gastrointestinal stapling.

It is another object to provide an improved device for effectivelysecuring medical devices to a patient's inner mucosa and reversiblyremove the staple.

It is a further object to provide an improved apparatus for securing aGARD valve to a hiatus hernia or wall of a gastro-intestinal tract of apatient suffering from severe GERD associated with a hiatus hernia.

A still further object is to provide an improved staple for stomachstapling surgery to treat obesity and a method of reversing suchstapling surgery for obesity.

It is also an object to place a manometric probe or several manometricprobes in the colon to treat Irritable Bowel Syndrome (IBS).

A still further object is to use the clips to staples with a joiningring and make stomach folds in the cardia, i.e., the upper part of thestomach, to make pleats to treat mild to moderate GERD.

A still further object is to use the staples to create a small reservoirin the upper part of the stomach to create a restrictive pouch in thestomach to treat moderate obesity, creating a reversible endoscopicvertical banding gastroplasty.

It is a further object to use pairs of staples to create a horizontalline of stapling creating a small gastric cavity at the top of thestomach, at the cardia, mimicking endoscopically the gastric pouchobtained by the laparoscopic banding (LAP-BAND) operations for obesity.

It is a further object to provide an improved device for effectivelysecuring restrictive and bypass tubes to treat obesity, called OB tubesas described in PCT/US06/35568.

SUMMARY OF THE INVENTION

These objects, and others which will become apparent from the followingdisclosure, are achieved by the present invention which in one aspectcomprises a gull shaped staple having two wings and a central loop, thestaple formed from a single length of flexible, resilient metal alloywire. The wings may be folded inward for insertion in a catheter of thetype used for flexible endoscopy. The staple may be placed by a surgeon,gastroenterologist, or other medical professional, using a flexiblecatheter with a grasping forceps in the catheter, placed through theworking channel of a gastroscope or endoscope. For loading the staple,the grasping forceps grasps the central loop of the staple and pulls thestaple in the catheter. The catheter is placed through the workingchannel of the endoscope. When in position the tip of the catheter isfirmly applied against a device being implanted or against tissue forstapling, the grasping forceps is pushed out of the catheter, whichexpels the staple. The staple immediately resumes its original wingshape so that the wings open and the staple is placed in position.

In order to remove the staple, under endoscopic control, the tooth ofthe grasping forceps seizes the loop in the middle of the staple and thestaple is pulled back into the catheter. Then the catheter with graspingforceps and staple can be removed out of the body of the patient.

Another aspect of the invention is a surgical method comprisingattaching a medical device to the inner mucosa of a gastro-intestinaltract of a patient with a the gull shaped staple using a conventionalstraight viewing video or fiberoptic endoscope or a lateral viewingendoscope for positioning of the staples. In order to assure stabilityand avoid a back jump of the flexible endoscope while firing, aninflatable balloon can be attached at the tip of the endoscope andinflated before firing the staple. The balloon is deflated after firingso that the forceps can move and release or ungrasp the staple.Alternatively, an overtube with an internal part sold by US Endoscopyunder the name the Guardus overtube can also be used with or without theinternal introducer part to give stiffness to the endoscope when firingthe staple.

Another aspect of the invention is a surgical method comprisingattaching medical devices to the inner mucosa of a gastro-intestinaltract of a patient with a the gull shaped staple using ultrasound realtime visualization and a flexible endoscope in order to determine exactpenetration of the wall of the GI tract.

An additional aspect of the invention is an article useful forimplanting a medical device comprising an electrical lead, a flexiblejoining member, and a gull shaped staple at a terminal end used forattaching an electronic pace setter.

Another aspect is a method of implanting a medical device having anelectrical lead comprising providing a terminal staple of theaforementioned gull shaped configuration on an electrical lead or aflexible joining member attached to an electrical lead, placing thestaple in a first lumen of the lumen catheter, injecting saline solutionthrough the second lumen, and using ultrasound to implant the staple,thereby fixing the electrical lead of the medical device in apredetermined layer of the GI tract.

Another aspect of the invention, a device as described in my U.S. Pat.No. 6,764,518, referred to as the GARD device, can be inserted throughthe mouth and the esophagus and, when located at the intersection of theesophagus and stomach mucosa, a ring portion of the GARD device isstapled to a hiatus hernia with the gull shaped staples using a flexibleendoscope with forward view or lateral view as in a standard gastroscopeor a lateral view duodenoscope, which facilitates precise placement andstapling. In some embodiments the ring described in my aforementionedU.S. Pat. No. 6,764,518, FIG. 1, is modified. Oval holes are punchedthrough the ring at regular intervals around the circumference. Incertain embodiments, the spring in the ring has 10 loops and, underevery second loop, an oval hole is punched through the ring. The ovalhole has to be wide enough to fit the tip of the flexible catheterholding the staple. Around the ring, a narrow 0.2 mm to 0.3 mm net ormesh of polypropylene or a net made of another biocompatible materialdipped in silicone is glued around the ring to close the holes. Thisconfiguration allows the tip of the catheter with the staple to fit intothe niche created by the holes to avoid slippage of the catheter beforeshooting the staple. Also, the thinner wall created by the net willallow the staple to hold the ring and attach the ring and the device tothe wall of the esophagus/hernia. In order to make the oval holes morevisible endosopically, a colored marking such as a black ring ofbiocompatible silicone around the hole can be added to make the nichemore visible for the endoscopist and help him/her see the holes forstapling.

In certain embodiments, a balloon is attached outside of the endoscope.Before shooting the staple with the catheter, the balloon is inflated.The inflated balloon blocks the tip of the endoscope in the ring of theGARD device or the ring of the OB tubes and prevents the endoscope fromjumping back or backfiring when the staple is fired. The inflation ofthe balloon allows better penetration of the staples through the ringand into the tissues without risking a back movement of the flexibleendoscope and incomplete penetration of the staple, which can happenwhen no balloon is used. After the staple is fired, the balloon isdeflated. The selection of the diameter of the inflated balloon dependson the diameter of the endoscope and the inner size of the ring. Thediameter of the inflated balloon in some embodiments is between 5 mm and25 mm, preferably between 10 mm and 20 mm. The purpose of the balloon isto make the tip of the flexible endoscope more rigid. Alternatively theinner tube of a Guardus overtube can be used. The inner tube acts like arigidifying sheath for the flexible endoscope and allows betterpenetration of the staples through the silicone ring, closing the holesand the tissues to which the device has to be attached.

In the case of surgical treatment of obesity, the invention comprises adevice as described in my PCT/US06/35568 filed Sep. 11, 2006, which ishereby incorporated by reference, describing a GARD and an alternativeprocedure to staple the stomach endoscopically and reversibly verticallyor horizontally in order to do a gastric restrictive operation formoderate obesity or yet to staple a by-pass tube from the esophagus tothe small bowel and pace the gastro-intestinal tract to allowprogression of the alimentary bolus for morbid obesity.

In my PCT/US06/35568 in which tubes with an upper ring to treat obesityare described, said upper ring may also be modified with oval holes andnetting wrapped around the ring to allow implantation of the reversiblestaples. The holes can be underlined in some embodiments with adifferent color biomaterial such as black silicone.

In some embodiments, the staple of the invention is constructed of asingle length of nitinol wire formed into a central loop, twoparallel-like arms with each of the arms extending from the paralleldirection in two opposing courses formed of an arc extending upwardlyand outwardly and two ends comprising sharpened endpoints, the endpointbeing more than about 0.5 mm above the top part of the central loop,depending on the size of the staple, the arms bendable under resistance;the article adapted to fold so as to fit within a flexible tube havingan internal diameter of about 2 mm to 4 mm and to unfold elasticallywhen pushed out of the tube at a location through the medical device.

The staple is preferably constructed of nickel-titanium alloy, andstaples of such material are novel and advantageous for several reasons.In most embodiments the staple will use the hyperelastic characteristicof nickel-titanium alloy, allowing folding under stress in a narrow tubefor placement in a catheter and resuming the original position whenunstressed without permanent deformation of the staple.

For applications where temporary staples are needed, the staples can beconstructed of biodegradable material, as long as the material iselastic enough to return to normal position after bending the tags to asubstantially parallel position during the insertion steps. Suchtemporary applications include stapling to the esophagus orgastro-intestinal tract of captors monitoring pressure, pH and/ortemperature or any other physical parameter. The biodegradable staplecan be made of absorbable materials such as lactide, glycolide, ore-caprolactone for such temporary placement.

For permanent applications such as with a GARD device, the flexiblejoining material can be made in implant grade steel, nitinol, surgicalthread, or implant grade polymer such as nylon, for example. However,nitinol (nickel-titanium alloy) is the preferred material because of itshyperelastic characteristics. The wing at each end of the joining membercan also be made of steel, nitinol, implant-grade polymers such as nylonor any other biocompatible implantable material. In a preferredembodiment, the wing and flexible joining segment are each made of anon-absorbable material, preferably the aforementioned nitinol alloywhich exhibits the flexibility needed when released from the catherer.In most cases the staples are constructed in an hyperelasticnickel-titanium alloy that does not use the configuration changes frommartensite to austenite. The hyperelastic characteristics of thenickel-titanium alloy allows the staples to be pulled (loaded) in arelatively narrow catheter of 2 mm to 3.0 mm in diameter and whenreleased to conserve the hyperelastic characteristics and almostinstantly resume the original wing shaped configuration to function as astaple. To remove the staple, in one embodiment a toothed forceps graspsthe loop of the staple and the staple is pulled back into the catheterfor removal through the endoscope. An important advantage of certainembodiment of the invention is the reversibility of the staplingoperation and the simplicity of the removal of the staples.

For treatment of IBS, one or more manometric probes are placed in thecolon using the stapling system of this invention. The manometric probesare described in PCT/US03/13773, which is hereby incorporated byreference. The staple can attach a device to the alimentary tract butcan also be used directly on the mucosa, often in pairs linked by acentral ring, either to create a pleat or to staple two opposite wallsof the alimentary tract together as in stapling the posterior wall tothe anterior wall to create a gastroplasty. Also, part of each staple isflat, not curved, so as to stay in the muscularis layer of thegastro-intestinal tract. The staple ends are sharpened but atintroduction the hyperelastic nitinol staple can be introduced in asmaller needle and, when released in the tissues, adopts the originalconfiguration. Also, when using an endoscope, the catheter can be placedin a niche of a ring to avoid slippage, then the staple can be expelledthrough the catheter with a hook or a small forceps.

Several shapes of symmetrical staple wings can be used in order to allowsuitable stapling force, yet allow the staple to be removable.

The staples can be kept at room temperature as their hyperelasticcharacteristic is used in stapling reversibly at flexible endoscopy.

In order to attach two opposite staples together to create as gastricreservoir to treat obesity in a vertical or horizontal line of staples,two staples are first placed opposite to each other on the posterior andanterior walls of the stomach. Then a thread is passed with a forcepsand the flexible endoscope through the mouth and through the centralring of the staple and pulled out again. A standard gastroscope or,preferably, a double channel endoscope, can be used to facilitate thepassage of the thread through the central loop and pulling it throughthe loop and out again. The same procedure is repeated with the otherstaple. Two double threads are then at the mouth of the patient and asmall thin-walled titanium tube is then slid over the four pieces ofthread through the mouth and esophagus into the stomach, allowingapproximation of the anterior and posterior walls. Once the smalltitanium tube is in placed near the two central rings of the twostaples, the tube is crimped with a forceps passed in the second workingchannel of the endoscope. The four threads are cut and the sameprocedure is repeated to create a small reservoir. A horizontally placedline of staples can be placed with a small opening for food. Thisoperation mimics the laparoscopic banding operation, with the advantageof being done non-invasively through the mouth with staples that arereversible. Alternatively, a small circular joining element can attachboth central loops of the two staples together.

In some embodiments a tilt-tag is attached to the central loop with anon-resorbable surgical thread to prevent the staple from being placedtoo deeply and to help in retrieving the staple.

When a tilt-tag is used, a catheter having an outer sheath and a forcepswith a tooth can be used to grab the central loop and pull the stapleinto the catheter to load the catheter and place the tilt-tag in theouter sheath. In some embodiments the catheter can have a long flexiblepart and a short metal tube, for example about 3 to 4 cm, which willlodge the staple. The end of the catheter can be cut in order to end asa short 3 mm needle with a thin slit in the upper part of the tube tolet the surgical thread linking the staple in the flexible catheter andthe tilt-tag placed in the outer tube. The staple with tilt-tag isloaded by pulling the central loop of the staple into the catheter withthe toothed forceps, for example. The surgical joining thread passesthrough the narrow slit of the needle and the tilt-tag is placed in theouter sheath. In these embodiments, a larger diameter catheter may beneeded in order to accommodate the tilt-tag in the outer sheath. In someembodiments an endoscope or gastroscope with a 3.7 mm or larger channelsuch as the Olympus GIF 1T 30, a GIF XT30, a FIG 2T 20, or videoendoscope XTQ 160 can be used. Certain endoscopes have multiplechannels, which are suitable for use with staples having tilt-tags.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a illustrates a top view of an embodiment of a staple accordingto the invention.

FIG. 1 b illustrates a side elevational view of the staple of FIG. 1 a.

FIG. 1 c illustrates a side elevational view of a second embodiment of astaple of the invention.

FIGS. 2, 3, 4, and 5 illustrate several additional embodiments of thestaple according to the invention.

FIG. 6 a illustrates an embodiment of a rounded tip grasping forcepsholding a staple.

FIG. 6 b illustrates an embodiment of a rounded tip grasping forcepsholding a staple folded in a flexible tube

FIG. 7 a illustrates an embodiment of a needle tipped flexible catheterwith a stopper and a hook.

FIG. 7 b illustrates an embodiment of a staple being grasped by aflexible catheter.

FIG. 7 c illustrates an embodiment of a staple pulled into a catheter.

FIGS. 8 a to 8 c illustrate the different stages of one of theembodiments of the staple when it is loaded then fired.

FIG. 9 a illustrates a perspective view of a needle with a hook in acatheter grasping one staple according to the invention.

FIG. 9 b illustrates a perspective view of a needle with a two-prongedrounded tweezer in a catheter loaded with one staple according to theinvention.

FIG. 10 illustrates a partial cutaway view of an esophagus with astraight viewing endoscope and a rounded end catheter inserting onestaple of the invention through both a gastrointestinal anti-refluxdevice (GARD) and the inner mucosa.

FIG. 11 illustrates a partial cutaway view of the esophagus with alateral viewing endoscope, a needle catheter, and a balloon insertingone staple of the invention through both a GARD and the inner mucosa.

FIGS. 12 a and 12 b illustrate a side elevational cutaway view and a topcross-sectional view of a GARD stapled to the inner mucosa in themuscularis layer of the mucosa, with the staple being pulled out towardthe inside in an uninstalling operation.

FIG. 13 illustrates the positioning of staples in pairs through astraight viewing gastroscope in order to create pleats to treat mild tomoderate gastrointestinal reflux disease (GERD). A larger balloon (notshown) can be used to apply the end of the endoscope to the mucosa.

FIG. 14 illustrates the OB device stapled to the lower part of theesophagus or in a hiatus hernia.

FIG. 15 illustrates a vertical series of pairs of staples stapling theanterior wall of the stomach to the posterior wall and creating avertical banding gastroplasty for obesity, endoscopically and withreversible staples.

FIG. 16 is a cross-sectional view of posterior and anterior walls of astomach stapled with two staples and joined with a ring.

FIG. 17 is a top view of two staples joined by a small open ring throughthe loops of the staples.

FIG. 18 is a partial cross-sectional view of a stomach which illustratesa horizontal line of staples creating a small reversible reservoir totreat obesity.

FIG. 19 is a view of two double threads placed through the loops of thestaples and a cross-sectional view of a thin-walled tube sliding on thethreads in order to join two stomach walls and create a gastricreservoir.

FIG. 20 illustrates the tube of FIG. 19 that has been crimped andblocking the threads to create the gastric reservoir.

FIG. 21 illustrates how two pairs of double threads passed in thecentral loop held together by the crimped tube separate the top part ofthe gastric reservoir from the main portion of the stomach in thebottom.

FIG. 22 is a cross-sectional view of a stomach and a perspective view ofa GERD tube stapled from the lower esophagus along the lesser curvatureof the stomach passing the middle of the stomach, creating a verticalreservoir similar to vertical banding gastroplasty.

FIGS. 23 a thru 23 e illustrate different lengths of OB tubes creatinginternal by-pass tubes stapled from the lower part of the esophagusthrough the stomach (FIGS. 23 a and 23 b) duodenum (FIGS. 23 c and 23 d)or junction of duodenum and jejunum (FIG. 23 e).

FIG. 23 f illustrates a long OB tube reaching the jejunum and with apace-maker and leads.

FIG. 24 illustrates a removable staple holding a manometric probe in thelumen for treatment of Irritable Bowel Syndrome (IBS).

FIG. 25 is a perspective view of an embodiment of a staple and tilt tagjoined by surgical thread.

FIG. 26 is a perspective view of a staple joined by surgical thread to asecond embodiment of a tilt tag via a knot of thread.

FIG. 27 is a perspective view of a staple joined to a tilt tag via ahook or ring at the distal end of the tilt tag.

FIG. 28 is a GARD tube with placed in an esophagus, the tube havingholes for placement of staples.

FIG. 29 is a view of a staple with tilt tag being inserted through ahole in a GARD ring with a flexible tube having a stopper.

FIG. 30 is a view of a staple being inserted through a hole in a GARDring with a flexible tube, forceps, outer sheath, tag, and thin netsystem.

FIG. 31 is a side elevational partial cross-sectional view of a flexiblecatheter having a needle formed from a metal tube cut at a slant withedges sharpened, a forceps with a tooth in the central lumen of theneedle, a stopper to limit the depth to which the needle may beinserted, a staple with tilt tag joined by surgical thread illustrateddistal to the tip of the needle prior to being grabbed by the teeth ortooth of the forceps.

FIG. 32 is a side elevational view of the catheter-needle-forceps systemillustrated in FIG. 31, illustrating the staple being pulled into theneedle by action of the forceps grabbing the central loop of the stapleand pulling in a proximal direction, with the tilt tag located in thelumen of the outer sheath but outside of the needle.

FIG. 33 is a top elevational view of the catheter-needle forceps systemof FIG. 32, illustrating a lateral slit in the sharpened needle whichreceives the surgical thread connecting the tilt tag and staple when thestaple is pulled into the needle and the tilt tag is placed in the lumenof the catheter outside of the needle.

FIG. 34 is a side elevational cross-section of a staple-loop-thread-tilttag system with the staple inserted through a hole in the GARD ring andthrough the net of the GARD, with the central loop of the staple withinthe ring and through the net of the GARD, with the central loop of thestaple within the hole and the tilt tag loosely connected with thread tothe central loop and disposed on the inside of an esophagus.

FIG. 35 is a similar view to FIG. 34, illustrating the thread passed inthe ring or hook at the ends of the tilt tag and the tilt tag tightenedagainst the central loop of the staple.

FIG. 36 illustrates a pair of staples inserted in two tissue walls of astomach with tilt tags facing each other and thread from the firststaple-tag system being used to join the second staple-tag system of thepair.

FIG. 37 illustrates the pair of staples of FIG. 36 wherein the threadhas cross-hooked the opposing tilt tags and has tightened the tilt tagstoward each other so as to draw the two opposing tissue walls towardeach to form a gastric stapling.

DETAILED DESCRIPTION

Referring first to FIGS. 1 a and 1 b, an example of a staple 10 of theinvention is shown wherein a first 1 and a second 2 wing are joinedperpendicularly at respective ends of joining member 3. In theillustrated embodiment, the staple 10 is molded in one piece fromNitinol, commercially available nickel-titanium alloy. Distance A inFIG. 1 a varies between 4 mm and 30 mm but preferably 6 mm to 20 mm, andmore preferably 10 mm to 16 mm. Preferably, the distance from the bottomof the loop to the endpoints is about 2.0 mm or more to avoid theendpoints piercing back into the lumen. Distance B can vary between 1 mmand 5 mm depending on the organ in which the staple is used (the stomachis much thicker than the esophagus or small and large bowel) butpreferably is about 3 mm. Distance D in FIG. 1 b can vary between 2 mmand 10 mm depending on the organ in which the staple is used (thestomach is much thicker than the esophagus or small and large bowel).Distance C in FIG. 1 b can vary between 0.5 mm to 4 mm, more preferablyabout 2.0 mm. Importantly, Distance E which determines the distancebetween the base of the central loop 3 and the sharpened tip of wing 4can vary between −2 mm and 10 mm (depending on Distance D), having anegative value when the tip 4 is below the base of the central loop 3(FIG. 1 c).

Referring to FIG. 2, an example of a staple 10 of the invention is shownwherein a first wing 1 and a second wing 2 are parallel at a portionadjacent to central loop joining member 3. Each of the wings 1 and 2extend from the parallel direction in two opposing courses forming anarc 5 extending upwardly and outwardly and two ends 4 comprisingsharpened endpoints, the endpoint being in this example a Distance D, of1.0 mm above the top part of the central loop, but can be varied,depending on the size of the staple. Distance A, the width of thestaple, is 15 mm in this example, and distance F, the length of theparallel segment between the bottom of the loop 3 and the beginning ofthe arc 5, is 3.0 mm in this embodiment.

Staple 10 is preferably molded in one piece from nickel-titanium alloysuch as Nitinol, a brand of commercially available nickel-titaniumalloy.

Referring now to FIGS. 3, 4 and 5, several variations of the staples areillustrated. In FIG. 3 both wings 1, 2 of the staples 10 are roughlyperpendicular to the parallel elements la and 2 a. In FIG. 4 the endshave an S shape and in FIG. 5 the ends are facing backwards towards thecentral loop.

Referring now to FIGS. 6 a and 6 b, the staple 10 is pulled (FIG. 6 a)with a grasping forceps 6 with a little tooth 12 and inserted in aflexible catheter 7 which is slightly wider than the diameter of thejoining member, allowing both wings to bend inside the flexible catheter7 as in FIG. 6 b. The flexible catheter 7 acts as a sheath for theforceps 6 and staple 10 assembly. The flexible catheter 7 is preferablymade in a Pebax thermoplastic elastomer flexible tube. A short tube 8can be welded, glued or otherwise attached at the end of the Pebaxflexible tube to avoid excessive friction of the endpoints 4 of thestaples 10 when loading into the catheter 7 and particularly whenexpelling of the staple 10 in tissue is desired.

The flexible Pebax catheter 7 with the forceps 6 and the staple 10 arepassed in the working channel of a standard endoscope. In order to placethe staple 10 in tissue or through a medical device such as a GARD, therounded tip 9 of the catheter 7 is placed against the device or tissuethat has to be stapled (FIG. 10) and the staple 10 is pushed out withthe forceps 6.

Referring to FIGS. 7 a and 7 b, a variation of the catheter is presentedwhere the rounded end as in FIG. 6 a is alternatively a sharpened needle11. Rather than a tooth 12, a small hook 14 is used to grab the staple10 by its central loop 3. In order to control the depth of penetrationand to avoid causing lesions of organs beyond the wall of the esophagusor hernia such as the aorta or vena cava, a stopper 13 can be placed ata predetermined distance from the tip of the needle 11, for examplebetween about 3 mm and 20 mm, and preferably about 4 mm to 6 mm. Suchstopper can be used to hit the inner wall of the GARD and avoid deeppenetration. Alternatively, a mark (not shown) on the needle 11 caninform the surgeon of the depth of penetration but will not control it.An echoendoscope EUS (not shown) could also be used for that purpose,however few endoscopists use EUS echoendoscope on a regular basis. Astopper or echoendoscope are not necessary when a round end catheter 9(FIG. 6 a) is used and the staple 10 with sharp endpoints 4 is used tostaple the device and penetrate tissue, which is an advantage of theembodiment of FIGS. 6 a and 6 b.

Referring now to FIG. 8 a, a staple 10 is shown being grabbed by centralloop 3 and being pulled in the direction of the arrow into the roundended flexible catheter 7 with the forceps 6. In FIG. 8 b, the catheter7 is shown loaded with the staple 10 being held by forceps 6.

FIG. 8 c illustrates firing out the staple of the round end of catheter7 in tissue 15.

Referring now to FIG. 9 a, a different embodiment of forceps 6 has ahook 16 that pulls the staple 10 in the flexible catheter 7.

FIG. 9 b illustrates a staple 10 having been loaded in a catheter 7 withforceps 6 having hook 16.

Referring now to FIG. 10 GARD 100 anti-GERD valve is shown in place andthe flexible catheter 7 with round end 9 have been passed through theflexible endoscope 16 through an overtube 17. The round tip 9 of thecatheter 7 has been placed in a niche of the ring 80 and the staple 10is positioned in the wall of the hernia 90. Several staples 10 will beplaced around the perimeter of the ring 80. In this embodiment thecentral loop 3 acts to prevent staple 10 from going all the way throughring 80.

In this way, without tying complicated knots or using any pledgets orother devices to attach the free piece of thread, a reversible staplecan be placed through the inner wall of the gastrointestinal tract andhold any device in place that needs to be held either for a long periodof time such as the GARD that is placed for years, or shorter periods oftime such as pressure, pH monitoring devices or other pressure devicesthat can be placed for a few weeks. When used with absorbable staplesthe monitoring devices will fall in the lumen of the esophagus, stomachor bowel once he staples and joining segment dissolve and will beexpelled naturally. When used with the reversible staples, each staple10 can be recovered by flexible endoscopy by pulling on the central loop3.

Referring to FIG. 11 a lateral viewing endoscope 160 (or a standardstraight viewing endoscope) is placed through an overtube 17, andballoon 300 is blown to offer a certain amount of counter-pressure. Thestaple 10 is placed in the ring 80 of the GARD 100 for reversiblestapling using the balloon 300 to maintain the forceps 6 toward the ring80.

Referring to FIG. 12 a an enlargement shows staple 10 in the muscularlayer of the gastro-intestinal wall 15. Removal of the stapleillustrated in FIG. 12 b which shows a direction arrow toward the insideof esophagus 15 with staple 10 being pulled by central loop 3.

Referring to FIG. 13, staples 10 are placed in pairs at the cardiaregion of the stomach 60, creating a pleat 70 to block mild reflux. Theendoscope 160, overtube 17, and needle 7 catheter with forceps 6 arealso shown. The overtube or the inner part of the Guardus overtube soldby US Endoscopy can act as a counterpressure device where the ballooncannot be used because the stomach organ is large.

Referring to FIG. 14 staples 10 attach an obesity OB 200 device usingthe same technique as described in placement of the GARD in FIG. 13. OBtubes 200 are preferably those disclosed in my U.S. Pat. No. 5,861,036which is hereby incorporated by reference and are usually longer than 10cm for treatment of obesity, using the ring disclosed in U.S. PatentPublication 20030009239 of Jan. 9, 2003, also incorporated by reference,preferably with the ring 80 having a zig-zag shaped nitinol spring 81.

Referring to FIG. 15, a vertical reservoir 82 is made along the lessercurvature with a series of removable staples placed in pairs 10 a and 10b and linked together to staple the posterior wall of the stomach 61 tothe anterior wall 62 as shown in FIG. 16. This operation, madeendoscopically with a straight viewing endoscope, allows a reversiblereservoir to be made to treat obesity.

FIG. 17 shows detail of the linking of the two staples 10 a and 10 b ofa pair. The staples 10 a and 10 b can be linked by a ring 20 or suturedtogether by two threads as illustrated in FIG. 18 which shows ahorizontal endoscopic reversible stapling of the stomach for obesity. Asmall reservoir is made in “A”. An anterior reversible staple 10 a isplaced on the anterior wall 62 with a double thread 30 to the mouth, asecond reversible staple 10 b is placed on the posterior wall 61 of thecardia of the stomach 30 with a thread 30 and a small tube 40 is slidfrom the mouth on both threads and crimped in place 50 as illustrated inFIG. 19, FIG. 20 and FIG. 21. Both threads are cut as in FIG. 21. Thisprocedure is repeated along the width of the cardia leaving a smallpassage for food. This procedure creates a reservoir A similar to thereservoir currently created by the prior art laparoscopic band, butendoscopically and reversibly according to the invention.

The process of linking two staples can also be used to repair tears in astomach or esophagus. Such tears can be accidental or can beintentional. A relatively new technique involves intentionallyperforating the stomach in order to do operations endoscopically butoutside of the stomach. A problem faced in the use of this new techniqueis how to close the perforations which were intentionally made. The useof two staples 10 and 10 a (FIG. 17) with thread connecting them, one oneither side of the tear, can be used to repair such tears.

Referring to FIG. 22, an obesity tube 200 is introduced in the stomach60, stapled 10 to the hiatus hernia 90. This tube 200 creates a smallreservoir as in FIG. 14 but is longer and easier to staple in place thancreating a reservoir as in the operation described in FIG. 15 with aseries of pairs of staples.

Referring to FIG. 23 a, an internal by-pass tube 200 is introduced inthe stomach and stapled 10 to the lower esophagus or hiatus hernia 90,allowing food to pass directly into the stomach 60.

FIG. 23 b illustrates total gastric bypasses according to the invention.

FIG. 23 c illustrates total gastric bypass and partial duodenum 83bypass with bypass tube 200 and stapled 10 to lower esophagus 84.

FIG. 23 d illustrates a total gastric 60 bypass and total duodenum 70bypass tube 200. The tube 200 can be semipermeable to allow fluids topass but stops food particles to enter the stomach 60, duodenum 83, andproximal jejunum 75, causing a calibrated malabsorption. The length ofthe tube 200 is calibrated according to the excess weight loss, creatinga “pseudo” short bowel syndrome.

FIG. 23 e illustrates a total gastric 60 bypass with total duodenum 83bypass and partial intestinal (jejunal 75) bypass.

FIG. 23 f illustrates a total gastric 60 bypass, total duodenum 83bypass, partial intestinal (jejunal 75) bypass with a stimulator in theform of a gastrointestinal pacemaker 500 and the leads 600. The tube canlet gastric and duodenal water secretions penetrate in the tube 200 butnot to leave it, thereby decreasing the length of small bowel used forabsorption of food and causing weight loss. The tube leaves space 65between the wall of the duodenum 83 and the external wall so that bilesecretion and pancreatic secretions as well as gastric secretions canflow freely. A stimulator 500 can be used to pace the stomach 60,duodenum 83 and small bowel to allow peristaltic contractions (notshown) transmitted to the inner tube for progression of the bolus offood in the tube. Contractions induced to the gastrointestinal tract bythe pace setter stimulator 500 increase the pressure in the bypass tube200.

Referring to FIG. 24 a staple 10 is placed in the wall of the colon 400using the same technique as described in FIG. 10 using a colonoscope orsigmoidoscope. The staple 10 holds a manometric probe 450 that transmitspressure readings telemetrically to a sensor 480 held outside the bodyto treat irritable bowel syndrome (IBS).

Referring to FIG. 25, an embodiment of staple 10 having a tilt tag 18attached with surgical thread 30 to central ring 3 and secured at tilttag hook 50 is illustrated. Using the tilt tag 18 helps preventimplantation of the staple 10 too deeply in either GARD ring 80 (FIG.30) or tissue 60 (FIG. 13).

FIG. 26 illustrates an embodiment of tilt tag 18 using a knot 11 ofthread 30 rather than the hook 50 of FIG. 25.

FIG. 27 illustrates thread 30 engaged to hook 50 of tilt tag 18.

FIG. 28 illustrates a GARD valve 100 having thick ring 80 with holes 19placed in esophagus 84. The ring 80 has a thin net 85, with siliconecovering holes 19.

FIG. 29 illustrates an example of a staple 10 with tilt tag 18 beinginserted through a hole 19 in a GARD ring 80 with a flexible tube 7having a stopper 13.

FIG. 30 is an embodiment of a staple 10 being inserted through a hole 19in a GARD ring 80 with a flexible tube, forceps 6, outer sheath 17, tag18, and thin net 85 system.

FIG. 31 shows a flexible catheter 7 having a needle 91 formed from ametal tube cut at a slant 92 with edges sharpened, a forceps 6 with atooth 93 in the central lumen of the needle, a stopper 13 to limit thedepth to which the needle 91 may be inserted, a staple 10 with tilt tag18 joined by surgical thread 30 illustrated distal to the tip of theneedle prior to being grabbed by the teeth or tooth 93 of the forceps 6.

FIG. 32 is the catheter-needle-forceps system illustrated in FIG. 31,illustrating the staple 10 being pulled into the needle 91 by action ofthe forceps 6 tooth 93 grabbing the central loop 3 of the staple 10 andpulling in a proximal direction, with the tilt tag 18 located in thelumen of the outer sheath 86 but outside of the needle 91.

FIG. 33 is a top view of the catheter-needle forceps system of FIG. 32,illustrating a lateral slit 94 in the sharpened needle 91 which receivesthe surgical thread 30 connecting the tilt tag 18 and staple 10 when thestaple 10 is pulled into the needle 91 and the tilt tag 18 is placed inthe lumen of the catheter 86 outside of the needle 91.

FIG. 34 illustrates a staple-loop-thread-tilt tag system with the staplewings 1, 2 inserted through a hole 19 in the GARD ring 80 and throughthe net 85 of the GARD, with the central loop 3 of the staple within thehole 19 and through the net 85 of the GARD, and the tilt tag 18 looselyconnected with thread 30 to the central loop 3 and disposed on theinside of an esophagus. The thread 30 passed in the ring or hook 50 ofat the ends of the tilt-tag 18 tightens the tilt-tag 18 against the loop3 of the staple.

FIG. 35 is a similar view to FIG. 34, illustrating the thread 30 passedin the ring or hook 50 at the ends of the tilt tag 18 and the tilt tag18 tightened against the central loop 3 of the staple.

FIG. 36 illustrates a pair of staples 10, 10 a inserted in two tissuewalls 15, 15 a of a stomach with tilt tags 18, 18 a facing each otherand thread 30 from the first staple-tag system being used to join thesecond staple-tag system of the pair.

FIG. 37 illustrates the pair of staples of FIG. 36 wherein the thread 30has cross-hooked the opposing tilt tags 18, 18 a and has tightened thetilt tags 18, 18 a toward each other so as to draw the two opposingtissue walls 15, 15 a toward each to form a gastric stapling.

While the invention has been described in detail and several embodimentshave been illustrated, other embodiments, alternatives, andmodifications should become apparent to those skilled in the art withoutdeparting from the spirit and scope of the invention.

1. (canceled)
 2. (canceled)
 3. (canceled)
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 5. (canceled) 6.(canceled)
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 8. (canceled)
 9. (canceled)
 10. (canceled) 11.(canceled)
 12. (canceled)
 13. (canceled)
 14. (canceled)
 15. (canceled)16. (canceled)
 17. (canceled)
 18. (canceled)
 19. (canceled)
 20. Asurgical method comprising providing a flexible endoscope and a flexiblecatheter having a lumen within the endoscope, providing a hook orforceps having a distal end in the lumen of the catheter, and providinga medical staple device having two elongated arms and a central loop,each of the arms normally extending from the loop in two opposinggenerally semicircular courses extending upwardly and outwardly from theloop, each arm having an end comprising a sharpened endpoint, the armsbendable under resistance and resuming their original position uponrelease distal to the hook or forceps in folded configuration with thetwo elongated arms folded inward in the lumen of the flexible catheter,positioning the distal end of the hook or forceps at a location in apatient's gastrointestinal tract where stapling is desired, releasingthe medical staple to cause the end points to pierce the patient's innermucosa and staple to the wall of the gastrointestinal tract, the medicalstaple device formed from a hyperelastic nickel-titanium (“nitinol”)alloy wire by bending the wire around itself, the staple.
 21. The methodof claim 20 comprising stapling a gastrointestinal anti-reflux device(GARD) having a collapsible ring, the method in a hiatus hernia at thejuncture of the patient's esophagus and stomach at a plurality oflocations.
 22. (canceled)
 23. The method of claim 20 wherein the stapleis constructed of absorbable material and the medical staple device iscomprises a sensor designed for temporary implantation in the patient.24. The method of claim 20 wherein the flexible catheter has a needlecomprising a stopper so as to predetermine the depth of penetration ofthe needle before the medical staple device is released and preventingpenetration of the needle beyond the wall of the alimentary tract andcausing a lesion to a nearby organ.
 25. The method of claim 20 whereinthe medical staple device comprises a pair of medical staples and isused for pleating the gastric mucosa, closure of tears or perforations,stapling of stomach, or stapling of bowel.
 26. The method of claim 20wherein the medical staple device is a used for placement of pace-makerleads and electrodes with a rigid trocar through the abdominal wall intothe stomach or from outside the stomach inward.
 27. The method of claim20 comprising implanting the medical staple device in the alimentarytract having an electrical lead connected to a pace-setter for pacingthe alimentary tract.
 28. The method of claim 20 comprising repairing atear in a stomach or esophagus by implanting a pair of the medicalstaples, one on each side of the tear, and then using surgical thread todraw the two staples toward each other.
 29. (canceled)
 30. (canceled)31. The method of claim 20 comprising releasing the medical staple bypulling the flexible catheter proximally.
 32. The method of claim 20comprising releasing the medical staple by moving the hook or forcepsdistally so as to force the staple forward.
 33. The method of claim 20wherein the medical staple includes surgical thread tied to the centralloop.
 34. The method of claim 20 wherein the medical staple includessurgical thread tied to the central loop and a tilt-tag attached or tiedto the surgical thread.
 35. The method of claim 20 comprising staplingwith the medical staple an anti-obesity reservoir at the lower part ofthe esophagus.
 36. The method of claim 20 comprising stapling aplurality of pairs of the medical staples create an endoscopicallyplaced vertical banding gastroplasty that is reversible by pulling outthe staples.
 37. The method of claim 20 comprising stapling with themedical staples an inner by-pass tube at the lower end of the intestineto create an internal intestinal by-pass.
 38. The method of claim 20comprising stapling pairs of medical staples to create an endoscopicallyplaced horizontal gastroplasty that is reversible by pulling out thestaples, and creating a reservoir for food at the cardia.
 39. The methodof claim 20 comprising reversibly stapling with the medical staples aninner gastric and intestinal by-pass tube at the lower esophagus totreat obesity.